Important Safety Information | NIOX VERO® User Manual (PDF)

For US Healthcare Professionals Only

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Frequently Asked Questions

Q: How long has fractional exhaled nitric oxide (FeNO) testing been available?

Measuring FeNO in patients with asthma has been investigated since the early 1990s. Aerocrine, now Circassia, was created by pioneers in FeNO research and launched the first commercially available FeNO-measuring device over 20 years ago.1 Today, Circassia remains committed and dedicated to FeNO instrumentation. Over 36 million FeNO tests have been performed worldwide using a NIOX® device.2




Q: Should I replace spirometry with FeNO?

FeNO is not a replacement for spirometry. FeNO measures nitric oxide in exhaled breath (which is increased in the majority of airway inflammation associated with asthma), while spirometry measures airflow limitation or obstruction. Both provide important information about different aspects of airway disease, such as asthma. For example, FeNO can provide information on the level of underlying airway inflammation, but it cannot tell you the degree of airflow obstruction. However, for treatment optimization, numerous studies in both children and adults indicate that adjusting inhaled corticosteroid (ICS) doses according to FeNO values gives reductions in asthma exacerbations of up to 50%, in patients at risk for future events as compared to traditional monitoring.3-5 Therefore, measuring FeNO in addition to spirometry is advised.3-8

Q: Is FeNO testing suitable for children?

NIOX VERO® is suitable for children, 7-17 years, and adults 18 years and older. NIOX VERO can be operated in two exhalation modes, 10 seconds or 6 seconds. The 10-second test mode is for age 7 and up, and the 6-second test mode is for ages 7-10 only when a 10-second test is not successful. NIOX VERO cannot be used with infants or by children under the age of 7 years, as measurement requires patient cooperation. FeNO can be measured in children aged 7 years and older with high success rates after coaching them through the procedure. FeNO can play an important role in the diagnosis and management of their disease.9,10 In several studies, asthma therapy directed by FeNO has been shown to reduce asthma exacerbations in children at risk for future events when compared with symptom-based care or usual care.3,5,13,14

Q: What factors besides asthma can affect FeNO measurements?

Other known causes may alter FeNO values. Significant allergic or respiratory disease or respiratory viral infections may affect FeNO.15 A diet rich in nitrate-containing foods may raise FeNO15-17 while smoking may reduce FeNO.11,18,19 Certain medications, particularly corticosteroids, can decrease FeNO.11,15 For additional information, please see the NIOX VERO User Manual, Section 9.3, Substances disturbing FeNO measurement.


Q: How do I calibrate my NIOX VERO device?

The NIOX VERO instrument does not require calibration. Sensors are calibrated directly against chemiluminescence methods during manufacturing and do not require re-calibration by the user.

Q: How often does my NIOX VERO instrument need to be serviced?

No servicing of the NIOX VERO device is required, minimizing any disruptions in testing during the operational lifetime of the device. Sensors are calibrated directly against chemiluminescence methods during manufacturing and do not require re-calibration by the user.

Q: Why does my NIOX VERO instrument expire?

Like other instruments, NIOX VERO has internal components that become depleted with use and will not last indefinitely. The operational lifetime of the instrument is a maximum of 5 years in use or 15,000 measurements or the expiration date, whichever comes first. The sensor has an operational lifetime of 12 months after installation or the expiration date (whichever comes first) and the breathing handle can be used for 1000 measurements or one year (whichever comes first).20 Aging and stability testing have confirmed that the instrument and components will provide accurate results throughout their stated shelf-lives and a robust Quality Assurance program is in place to ensure that the instrument and its components will consistently function over their operational lifespans. Note that any instrument that is purchased will have a lifespan of 5 years or 15,000 measurements, whichever comes first.


Q: How do I know when my NIOX VERO instrument will expire?

By accessing the instrument settings, the number of measurements remaining and the expiration dates of the NOIX VERO device and sensor can be verified. For step-by-step instructions, please see the NIOX VERO User Manual, Section 5.6.5, View instrument information. Also, alerts will display on the screen to inform the user of upcoming and past expiration dates for the instrument, sensor and breathing handle.20



Q: How do I dispose of used and/or expired NIOX VERO instruments, sensors and breathing handles?

Do not heat or dispose of the NIOX VERO instrument or sensor in fire.

  • Used or expired NIOX VERO instruments and breathing handles should be disposed of as hazardous waste in accordance with local waste disposal regulations.
  • Used or expired sensors should be recycled according to the local recycling program for electronic equipment.
  • Used batteries should be recycled according to the local recycling program for rechargeable batteries.
  • Used patient filters should be disposed of as biohazard waste.20


For complete information please see the NIOX VERO User Manual, Section 8.4, Disposal of instrument and accessories.




References

References: 1. Silkoff PE, Carlson M, Bourke T, Katial R, Ogren E, Szefler S. The Aerocrine exhaled nitric oxide monitoring system NIOX is cleared by the US Food and Drug Administration for monitoring therapy in asthma. J Allergy Clin Immunol. 2004 Nov; 114(5): 1241-56. 2.Data on file. Circassia Ltd. October 2019 C-NIOX-0002. 3. Peirsman EJ, Carvelli TJ, Hage PY, et al. Exhaled nitric oxide in childhood allergic asthma management: a randomised controlled trial. Pediatr Pulmonol. 2014 Jul; 49(7): 624-31. 4. Syk J, Malinovschi A, Johansson G, et al. Anti-inflammatory treatment of atopic asthma guided by exhaled nitric oxide: a randomized, controlled trial. J Allergy Clin Immunol Pract. Nov-Dec 2013;1(6):639-48.e1-8. 5. Petsky HL, Kew KM, Chang AB. Exhaled nitric oxide levels to guide treatment for children with asthma. Cochrane Database Syst Rev. 2016 Nov 9; 11(11): CD011439. 6. 6. Petsky HL, Kew KM, Turner C, Change AB. Exhaled nitric oxide levels to guide treatment for adults with asthma. Cochrane Database Syst Rev. 2016 Sep 1; 9(9): CD0114407. Smith AD, Cowan JO, Brassett KP. Herbison GP, Taylor DR. Use of exhaled nitric oxide measurements to guide treatment in chronic asthma. N Engl J Med. 2005 May 26; 352(21): 2163-73. 8. Alving K, Malinovschi A. Basic aspects of exhaled nitric oxide. Eur Respir Mon. 2010; 49: 1-31.  9. Turner S, Cotton SC, Emele CD, et al. Reducing asthma attacks in children using exhaled nitric oxide as a biomarker to inform treatment strategy: a randomized trail (RAACENO). Trials. 2019 Oct 4; 20(1): 573. Respir Med. 2013;107(7):943-952. 10. Wang X, Tan X, Li Q. Effectiveness of tractional exhaled nitric oxide for asthma management in children: a systemiatic review and meta-analysis. Pediatr Pulmonol. 2020 Aug; 55(8): 1936-45. Chest. 2012;142(6):1553-1561. 11. Dweik RA, Boggs PB, Erzurum SC, et al. on behalf of the American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FENO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications. Am J Respir Crit Care Med. 2011 Sep 1; 184(5): 602-15. 12. NICE Guideline (NG80). Asthma: diagnosis, monitoring and chronic asthma management. 29 November 2017. https://www.nice.org.uk/guidance/ng80/resources/asthma-diagnosis-monitoring-and-chronic-asthma-management-pdf-1837687975621 (accessed 03 September 2020). 13. Petsky H. Exhaled nitric oxide in children with asthma. Respiratory care nurse's perspective. Indian Pediatr. 2014 Feb; 51(2): 102-3. 14. Mahr TA, Malka J, Spahn JD. Inflammometry in pediatric asthma: a review of fractional exhaled nitric oxide in clinical practice. Allergy Asthma Proc. May-Jun 2013; 34(3): 210-9. 15. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15; 171(8): 912-30. 16. Olin AC, Aldenbratt A, Ekman A, et al. Increased nitric oxide in exhaled air after intake of a nitrate-rich meal. Respir Med. 2001 Feb; 95(2): 153-8. 17. Vints A-M, Oostveen E, Eeckhaut G, Smolders M, De Backer WA. Time-dependent effect of nitrate-rich meals on exhaled nitric oxide in healthy subjects. Chest. 2005 Oct; 128(4): 2465-70. 18. Malinovschi A, Backer V, Harving H, Porsbjerg C. The value of exhaled nitric oxide to identify asthma in smoking patients with asthma-like symptoms. Respir Med. 2012 Jun; 106(6): 794-801. 19. Marteus H, Mavropoulos A, Palm JP, Ulfgren A-K, Bergstrom J, Alving K. Nitric oxide formation in the oropharyngeal tract: possible influence of cigarette smoking. Nitric Oxide. 2004 Nov; 11(3): 247-55. 20. 20. NIOX VERO® User Manual US. 000190-13. Circassia Pharmaceuticals Inc. September 2019.